Cleared Special

Volcano iFR Harvest Software (Offline)

K143122 · Volcano Corporation · Radiology
Feb 2015
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K143122 is an FDA 510(k) clearance for the Volcano iFR Harvest Software (Offline), a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on February 20, 2015, 112 days after receiving the submission on October 31, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K143122 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2014
Decision Date February 20, 2015
Days to Decision 112 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1560

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